MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-16 for T4 12017709122 manufactured by Roche Diagnostics.
[4451035]
The customer received questionable results for thyroxine (t4), thyrotropin (tsh), and t-uptake (t-up) on one patient sample, and erroneous t4 results on a second patient when testing was performed on cobas e411 rack instrument with serial number (b)(4). Patient 1 had erroneous t4, tsh and t-up results that were reported outside of the laboratory, with no adverse events. These results were reported on the mdr with submission number 1823260-2014-02769. Please see the attachment to the mdr for a copy of these results. No further samples for patient 1 could be provided for evaluation; therefore a specific root cause could not be identified. Patient 2 had erroneous t4 results that were reported outside of the laboratory, with no adverse events. These data were reported on the mdrs with submission numbers 1823260-2014-02769 and 1823260-2014-02770. Please see the attachment to the mdr for a copy of these results. A specific root cause could not be identified. On (b)(6) 2014, patient 2 returned and had a new sample drawn, which generated erroneous t4 results on this instrument and another instrument. The t4 result from this instrument was 21. 7 ug/dl, which was reported to the physician. On (b)(6) 2014, the sample was sent to a sister facility and was run on a cobas 6000 e601 instrument and generated a result of 20. 0 ug/dl. The sample was then sent to another laboratory where it was run on a siemens instrument and generated a result of 12. 7 ug/dl. The customer believed the results from the other methodology to be correct. There was no adverse event. The customer believes the erroneous results are due to some interference in the sample and refused a service dispatch. The (b)(6) 2014 sample from patient 2 was requested for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
[11730653]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[11961420]
On follow up with the customer, they indicated that patient 2 is taking a vitamin d supplement and birth control pills. The patient also had additional thyroid results that were generated on this instrument on (b)(6) 2014. The patient had a "t3" result of 184 ng/dl, a t-uptake result of 1. 5 tbi, a tsh result of 0. 263 uiu/ml and a "t4, free" result of 1. 5 ng/dl. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[19396467]
The investigation determined that no interfering factors seemed to be present in the investigated sample. It was also determined that no interference from pharmaceuticals seemed to be present either. A general reagent issue was excluded. The difference between the elecsys and other assays could possibly be attributed to differences in methods and instruments, differences in standardization and applications and different antibodies.
Patient Sequence No: 1, Text Type: N, H10
[22007876]
Additional testing was performed during the investigation on the sample for patient 2: anti-tg: 58. 02 iu/ml anti-tpo: 86. 69 iu/ml.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-03479 |
| MDR Report Key | 3816208 |
| Report Source | 05,06 |
| Date Received | 2014-05-16 |
| Date of Report | 2014-07-28 |
| Date of Event | 2014-03-13 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2014-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | T4 |
| Generic Name | RADIOIMMUNOASSAY, TOTAL THYROXINE |
| Product Code | CDX |
| Date Received | 2014-05-16 |
| Model Number | NA |
| Catalog Number | 12017709122 |
| Lot Number | 17416501 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-16 |